Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3640](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3640) → OAT — Implant, Endosseous, Orthodontic # OAT · Implant, Endosseous, Orthodontic _Dental · 21 CFR 872.3640 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT ## Overview - **Product Code:** OAT - **Device Name:** Implant, Endosseous, Orthodontic - **Regulation:** [21 CFR 872.3640](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3640) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **Implant:** yes ## Identification An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function. ## Classification Rationale Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.) Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. ## Special Controls *Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use. ## Recent Cleared Devices (20 of 51) Showing 20 most recent of 51 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K242944](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K242944.md) | Leone Orthodontic Implant TAD (Temporary Anchorage Device) | Leone S.P.A. | Jun 19, 2025 | SESE | | [K231502](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K231502.md) | Mini Screws | Proimtech Saglik Urunleri Anonim Sirketi | Sep 4, 2024 | SESE | | [K231913](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K231913.md) | T-FIT | Techwin Co., Ltd. | Feb 8, 2024 | SESE | | [K222245](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K222245.md) | ACR Screw System | Biomaterials Korea, Inc. | Aug 21, 2023 | SESE | | [K202163](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K202163.md) | Mico One Orthodontic Screw | Ze Fang Technology Co., Ltd. | Oct 7, 2022 | SESE | | [K202691](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K202691.md) | Ortholock Anchorage Devices | Craniofacial Technologies, Inc. | Apr 28, 2022 | SESE | | [K210559](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K210559.md) | ATOZ Mini-Screw | Mk Meditech, Inc. | Dec 19, 2021 | SESE | | [K211992](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K211992.md) | Ortho MI System | Osteonic Co., Ltd. | Oct 15, 2021 | SESE | | [K202790](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K202790.md) | Syntec Orthodontic Mini Screw Extended System | Syntec Scientific Corporation | Sep 17, 2021 | SESE | | [K202278](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K202278.md) | OBS Anchorage Screw, Biokey Anchorage Screw | Bomei Co, Ltd. | Jan 8, 2021 | SESE | | [K201919](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K201919.md) | Blue Sky Bio TAD | Blue Sky Bio, LLC | Dec 17, 2020 | SESE | | [K191041](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K191041.md) | Orthodontic Fixation Screw [Smart Anchor Miniscrew] | Gni Co., Ltd. | Aug 28, 2020 | SESE | | [K190871](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K190871.md) | Bio-TackS Orthodontic Mini Implant | Biocetec Co., Ltd. | Jan 17, 2020 | SESE | | [K182929](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K182929.md) | BIO-RAY A-1 Anchor Screw System | Microware Precision Co., Ltd. | Nov 6, 2019 | SESE | | [K181142](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K181142.md) | Absoanchor Microimplant | Dentos, Inc. | Feb 5, 2019 | SESE | | [K173623](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K173623.md) | Anchor plate | Biomaterials Korea, Inc. | Aug 30, 2018 | SESE | | [K161335](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K161335.md) | Dual Top Screw System | Jeil Medical Corporation | Feb 23, 2017 | SESE | | [K161197](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K161197.md) | Orthodontic Screw | Osstem Implant Co., Ltd. | Dec 21, 2016 | SESE | | [K152297](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K152297.md) | OBS Anchorage Screw | Bomei Co, Ltd. | Feb 9, 2016 | SESE | | [K142001](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT/K142001.md) | SYNTEC WETALI ORTHODONTIC MINI SCREWS | Syntec Scientific Corporation - Taipei Office | Mar 18, 2015 | SESE | ## Top Applicants - Biomaterials Korea, Inc. — 4 clearances - Synthes (Usa) — 2 clearances - Osstem Implant Co., Ltd. — 2 clearances - Leone S.P.A. — 2 clearances - Dentaurum — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OAT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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